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Completed

NCT Number: NCT02984774

Assessment of Telomerase Activity in Endometrial Tissue and Serum in Endometriosis Patients

The goal of the study was the detection of telomerase activity in eutopic, ectopic endometrial tissue and in peripheral blood and finding the correlation between the telomerase activity and clinic findings. With these results, confirmation of the hypothesis regarding the endometriosis pathogenesis and endometriosis-related infertility was aimed.

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Key information

Conditions

Endometriosis Ovaries Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Infertility, Female Urogenital Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nigar Sofiyeva

Istanbul, Non-US/Non-Canadian, 34098, Turkey (Türkiye)

About this study

Although distorted pelvic anatomy, impaired peritoneal, humoral and cellular functions, decreased implantation rate, oocyte and embryo quality, obstructed utero tubal connection are most researched aspects of endometriosis-related infertility, etiopathogenesis of endometriosis-related infertility still remains controversial.

Endometrial cell is a unique eukaryotic somatic cell with cyclic telomerase activity. Hormone-dependent cyclic variation of endometrial telomerase activity was stated in previous studies. On the other hand telomerase, activity was shown in endometriotic lesions, whereas this activity lacks in most of the somatic cells.

In this study, assessment of possible relation to increased telomerase activity in infertile patients with endometriosis was aimed.

Before published studies were assessed telomerase activity in benign and malign gynecological conditions and in endometriosis tissue, as well. But evaluation of ectopic and eutopic endometrial tissue and serum telomerase activity in infertile and fertile endometriosis and healthy control subjects was not performed.

Correlation of telomerase activity and endometriosis-related infertility was aimed in this study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of Infertility Clinical and histological diagnosis of endometriosis

Exclusion criteria

Malign disorders Hormone replacement treatment Oral Contraceptive using

Treatment and study plan

Cystectomy

Procedure

Segment of cystic wall from the patients for planned cystectomy was taken after operation and was preserved at -80º Celsius for further analysis

Endometrial sampling

Procedure

Endometrial sampling was performed at the same operation with the planned operation for the main indication and was preserved at -80º Celsius for further analysis

Other names: Pipelle endometrial suction curettage

Peripheric blood sampling

Procedure

4 cc peripheric venous blood was sampled into the EDTA(Ethylenediaminetetraacetic acid)-containing tubes during catheterization for anesthesia was preserved at 4º Celsius for further analysis

Ovarian tissue sampling

Procedure

2cm linear tissue sample from ovarian cortex was performed at the same operation with the planned operation for the main indication and was preserved at -80º Celsius for further analysis

Primary outcomes

  1. Telomerase activity

    Time frame: through study completion, an average of 1 year

    Assessment of telomerase activity with Telomeric Repeat Amplification Protocol Polymerase Chain Reaction method from tissue and blood

Secondary outcomes

  1. Age in years

    Time frame: During admission to hospital for surgery

    From patient anamnesis

  2. Marital status (single, married, divorced, widow)

    Time frame: During admission to hospital for surgery

    From patient anamnesis

  3. Smoking status ( yes/no)

    Time frame: During admission to hospital for surgery

    From patient anamnesis

  4. BMI in kg/m2

    Time frame: During admission to hospital for surgery

    From patient anamnesis

  5. Cystic size in cm

    Time frame: During operation

    Macroscopically assessment during surgery

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Does Telomerase Activity Have an Effect on Infertility in Patients With Endometriosis ? Assessment of Telomerase Activity in Eutopic, Ectopic Endometrial Tissue and Serum

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 7, 2016
Registry last updated
Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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